Due to concerns about disruptions to the supply chain, FDA has posted guidance informing the pharmaceutical industry that it does not intend to enforce drug tracking requirements before May 1, 2015. The Drug Supply Chain Security Act ("DSCSA"), requiring drug trading partners to capture, maintain, and provide the subsequent purchaser with transaction information for certain prescription drugs, was set to take effect on January 1, 2015 for manufacturers, wholesale distributors, and repackagers. The compliance policy is limited to the requirements in the DSCSA that trading partners provide and capture product tracing information and does not cover other requirements, such as verification related to suspect and illegitimate products and requirements related to authorized trading partners.
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